Senior Manager, Quality Assurance
Department: Regulatory CMO/ Clinical
Employment Type: Full Time
Reference Number: 1735409
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib (MRTX849) and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule, potent and selective KRAS G12D inhibitor in preclinical development.
Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.
The Company has initiated plans to prepare for the commercialization of adagrasib by establishing its commercial and medical affairs team. Mirati's ambition is to continue to recruit and a build a world-class, high-performing team with a shared passion and dedication for transforming the future of cancer treatment.
We are Mirati
Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.
Why join us?
Our pipeline is one of the most robust and exciting in the industry and fuels our ambition to make great strides in the fight against cancer. By joining Mirati, you will become part of a leading biotech company with a team of talented professionals dedicated to bringing the latest innovations in cancer treatment to patients. With a focus on teamwork and a commitment to do everything we can to support healthcare professionals in their effort to care for patients, we are well positioned to raise expectations for what companies can do to advance cancer care. We are passionate and dedicated, nimble and fast and are committed to empowerment to enable speed and high-quality customer service. While we go about it, our commitment to do first what is right is unshakable and we promise to put patients first in all that we do.
The Senior Manager of Quality Assurance will report directly to the Director, Quality Assurance. The individual will be responsible for supporting the designated QA lead on Mirati project teams. Under the direction of the Director of QA, this role will be responsible for review of GMP operations at contracted vendors in support of Mirati's small molecule programs. Responsibilities may include reviewing applicable data in support of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions. The ideal candidate will have a strong quality assurance / GMP operations background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required.
Reporting to the Director, Quality Assurance; the Senior Manager, Quality Assurance will be responsible for supporting the Quality Assurance Operations function to ensure clinical trial material is manufactured and tested according to GMPs. The Senior Manager, QA will have the following responsibilities. These may include but are not limited to:
- Review of executed batch records and disposition batches, certifying compliance with study, regulatory and GMP requirements.
- Collaborate with Mirati CMC and Technical Operations colleagues to ensure timely technical reviews of batch records, escalating issues as necessary
- Participation in weekly vendor meetings
- Assist with review and approval of Master Batch Records & Packaging Records, etc.
- Complete Batch Record review checklists for batch disposition
- Generation of certificates of release and compliance, etc.
- Ensure GMP compliance is maintained
- Assist the Director of QA to assess investigations, and deviations and bring to closure in a compliant manner
- Provide the support required to ensure timely implementation of corrective actions and escalate as necessary
- Ensure products meet regulatory requirements
- Support the review and approval of CMO change controls as required
- May perform document change control activities (i.e., SOP writing) as needed
- Develop, revise, implement and adhere to Quality Assurance department policies and procedures
- Assist with maintaining file organization within the Quality department
- Other duties as assigned
What is Required:
- Bachelor's or Masters' degree in Life Sciences field or equivalent years' experience, with 8+ years pharmaceutical industry experience and a minimum of 6 years in Quality Assurance.
- Previous small molecule drug and NDA-level experience are a strong plus
- Established working knowledge of Good Manufacturing Practices and other applicable regulations (US and international).
- Quality Assurance experience supporting both development projects and commercial products.
- Experience working with management and key business stakeholders.
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
- Strong communication skills both written and oral.
- Ability to multi-task and shift priorities rapidly to meet tight deadlines.
- Professional demeanor and an excellent written and verbal communicator.
- Detail oriented and well organized.
- Good and thoughtful listener.
- Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.